γ-Interferon Detection Kit (Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 50 servings/box, 100 servings/box, 200 servings/box. Control (1): 1× lyophilized (optional), Control (2): 1× lyophilized (optional)
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242401939
- Approval date
- September 29, 2024
- Expiry date
- September 28, 2029
- Province/Region
- Jiangsu
- Address
- Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
- Production address
- 苏州工业园区星湖街218号生物纳米园B11号楼4楼、5楼,苏州市工业园区赵家上路7号
It is used for in vitro quantitative detection of the concentration of γ-interferon in human serum
用于体外定量检测人血清中γ-干扰素的浓度
Reagent 1: biotin-conjugated monoclonal antibody to γ-interferon (1) (approximately 0.5 mg/L, mouse derived), protein buffer (containing 1% bovine serum albumin, 0.1% Proclin300); Reagent 2: Acridine ester-conjugated monoclonal antibody to γ-interferon (2) (approximately 0.5 mg/L, murine derived), protein buffer (containing 1% bovine serum albumin, 0.1% Proclin300); Reagent M: Streptavidin-coated magnetic particles (approximately 0.3 mg/mL) with 0.1% Proclin300; Calibrator (1) (optional): protein buffer (containing 1% bovine serum protein, 0.1% preservative); Calibrator (2) (optional): containing γ-interferon antigen, (recombinant, E. coli, approx. 2.0 IU/mL) protein buffer (containing 1% bovine serum protein, 0.1% preservative); Calibrator (3) (optional): with γ-interferon antigen, (recombinant, E. coli, approx. 10.0 IU/mL), protein buffer (1% bovine serum protein, 0.1% preservative); Calibrator (4) (optional): with γ-interferon antigen, (recombinant, E. coli, approx. 50.0 IU/mL), protein buffer (1% bovine serum protein, 0.1% preservative); Calibrator (5) (optional): containing γ-interferon antigen, (recombinant, E. coli, approx. 500.0 IU/mL), protein buffer (containing 1% bovine serum protein, 0.1% preservative); Calibrator (6) (optional): with γ-interferon antigen, (recombinant, Escherichia coli, approx. 1000.0 IU/mL), protein buffer (with 1% bovine serum protein, 0.1% preservative); Control (1) (optional): with γ-interferon antigen, (recombinant, E. coli, approx. 10.00 IU/mL), bovine serum (0.1% preservative); Control (2) (optional): containing γ-interferon antigen, (recombinant, E. coli, approx. 500.00 IU/mL), bovine serum (0.1% preservative); 1 puncture tool: used for puncture of reagent bottle caps. QR code label: including reagent information, calibrator concentration, prefabricated calibration curve (calibrator 3 and calibrator 5 calibration and standard repair are used); Calibrator traceability: traceable to the γ-Interferon International Reference Material (NIBSC WHO code: 82/587).
试剂1:含生物素标记的γ-干扰素单克隆抗体①(约0.5mg/L,鼠源性),蛋白缓冲液(含1%牛血清白蛋白,0.1% Proclin300);试剂2:含吖啶酯标记的γ-干扰素单克隆抗体② (约0.5mg/L,鼠源性),蛋白缓冲液(含1%牛血清白蛋白,0.1% Proclin300);试剂M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),含0.1% Proclin300;校准品①(选配):蛋白缓冲液(含1%牛血清蛋白,0.1%防腐剂);校准品②(选配):含γ-干扰素抗原,(重组,大肠杆菌,约2.0 IU/mL)蛋白缓冲液(含1%牛血清蛋白,0.1%防腐剂);校准品③(选配):含γ-干扰素抗原,(重组,大肠杆菌,约10.0 IU/mL),蛋白缓冲液(含1%牛血清蛋白,0.1%防腐剂);校准品④(选配):含γ-干扰素抗原,(重组,大肠杆菌,约50.0 IU/mL),蛋白缓冲液(含1%牛血清蛋白,0.1%防腐剂);校准品⑤(选配):含γ-干扰素抗原,(重组,大肠杆菌,约500.0 IU/mL),蛋白缓冲液(含1%牛血清蛋白,0.1%防腐剂);校准品⑥(选配):含γ-干扰素抗原,(重组,大肠杆菌,约1000.0 IU/mL),蛋白缓冲液(含1%牛血清蛋白,0.1%防腐剂);质控品①(选配):含γ-干扰素抗原,(重组,大肠杆菌,约10.00 IU/mL),牛血清(含0.1%防腐剂);质控品②(选配):含γ-干扰素抗原,(重组,大肠杆菌,约500.00 IU/mL),牛血清(含0.1%防腐剂);刺穿工具1个:用于试剂瓶盖的穿刺使用。二维码标签:含试剂信息、校准品浓度、预制校准曲线(采用校准品3、校准品5校准修标);校准品溯源性:溯源至γ-干扰素国际标准物质(NIBSC WHO code:82/587)。
Unopened reagents, calibrators and quality controls are stored at 2-8°C with an expiration date of 18 months; The opened reagent is stable for 60 days at 2-8°C. The reconstituted calibrator is stable for 8 hours at 2-8°C and 72 hours at 2-8°C.
未开封的试剂、校准品及质控品2-8℃环境下储存,有效期18个月;开封的试剂,2-8℃环境下可稳定保存60天。复溶后的校准品,2-8℃环境下可稳定保存8小时复溶后的质控品,2-8℃环境下可稳定保存72小时。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for γ-Interferon Detection Kit (Chemiluminescence Immunoassay), registration 苏械注准20242401939. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.